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Clinical trialNCT01910389TerminatedPhase 3Interventional

Phosphodiesterase Type 5 Inhibition With Tadalafil Changes Outcomes in Heart Failure

SponsorCarelon ResearchEnrollment23Heart FailurePulmonary Hypertension
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This study is a multi-center, prospective, randomized, double blind, placebo-controlled clinical trial. Subjects in the study will be adults with New York Heart Association (NYHA) Class II-IV heart failure (HF) due to left ventricular systolic dysfunction (LVSD), left ventricular ejection fraction (LVEF) \<0.40, and secondary pulmonary hypertension (PH). The purpose of the study is to evaluate the safety, effectiveness, and effects of tadalafil compared to placebo on the subjects' functional capacity / quality of life.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

63 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada
  • Jewish General Hospital

    Montreal, Quebec, Canada

United States
  • Heart Center Inc - Research

    Huntsville, Alabama, United States

  • Baptist Health Transplant Institute

    Little Rock, Arkansas, United States

  • Allianz Medical and Research Center

    Fountain Valley, California, United States

  • Christiana Care Health System

    Newark, Delaware, United States

  • Broward Health

    Fort Lauderdale, Florida, United States

  • Miller School of Medicine University of Miami

    Miami, Florida, United States

  • Orlando Health

    Orlando, Florida, United States

  • Charlotte Heart Group Research Center

    Port Charlotte, Florida, United States

  • Brevard Cardiovascular Research Associates

    Rockledge, Florida, United States

  • University Cardiology Associates Llc

    Augusta, Georgia, United States

  • Eisenhower Army Medical Center

    Fort Gordon, Georgia, United States

  • Northwestern University

    Chicago, Illinois, United States

  • University of Illinois Hospital

    Chicago, Illinois, United States

  • Methodist Medical Group Cardiology

    Peoria, Illinois, United States

  • Baptist Hospital East

    Louisville, Kentucky, United States

  • Research Integrity Llc

    Owensboro, Kentucky, United States

  • Lsu Health Sciences Center

    New Orleans, Louisiana, United States

  • Maine Research Associates

    Auburn, Maine, United States

  • Johns Hopkins Hospital

    Baltimore, Maryland, United States

  • Primary Care Cardiology Research, Inc.

    Ayer, Massachusetts, United States

  • Brigham and Women'S Hospital

    Boston, Massachusetts, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, United States

  • Mgh West

    Waltham, Massachusetts, United States

  • University of Michigan Health System

    Ann Arbor, Michigan, United States

  • Oakwood Hospital and Medical Center

    Dearborn, Michigan, United States

  • Henry Ford Hospital

    Detroit, Michigan, United States

  • William Beaumont Hospital

    Royal Oak, Michigan, United States

  • Covenant Center for the Heart

    Saginaw, Michigan, United States

  • Essentia Health East

    Duluth, Minnesota, United States

  • Metropolitan Heart and Vascular Institute

    Minneapolis, Minnesota, United States

  • Mayo Clinic

    Rochester, Minnesota, United States

  • Missouri Cardiovascular Specialists

    Columbia, Missouri, United States

  • St. Luke'S Health System

    Kansas City, Missouri, United States

  • Glacier View Research Institute

    Kalispell, Montana, United States

  • Advanced Heart Care, Llc

    Bridgewater, New Jersey, United States

  • Hackensack University Medical Center

    Hackensack, New Jersey, United States

  • Newark Beth Israel Medical Center

    Newark, New Jersey, United States

  • Heart & Vascular Center of Nj/cardio Metabolic Institute

    Somerset, New Jersey, United States

  • New York Methodist Hospital

    Brooklyn, New York, United States

23 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Placebo for tadalafilTadalafil →
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Nov 2013
Primary completion
28 Feb 2014
Completion
28 Feb 2014
Last update posted
4 May 2015
Registered enrollment
23
Registry id
NCT01910389

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.